EP3034112B1 - Verfahren und system zur automatisierten verarbeitung biologischer flüssigkeit während eines niedrigen pegelalarmzustands - Google Patents

Verfahren und system zur automatisierten verarbeitung biologischer flüssigkeit während eines niedrigen pegelalarmzustands Download PDF

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EP3034112B1
EP3034112B1 EP15200469.3A EP15200469A EP3034112B1 EP 3034112 B1 EP3034112 B1 EP 3034112B1 EP 15200469 A EP15200469 A EP 15200469A EP 3034112 B1 EP3034112 B1 EP 3034112B1
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Prior art keywords
fluid
processing
hardware
errors
hardware unit
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English (en)
French (fr)
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EP3034112A1 (de
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Amit J. Patel
Samantha M. Planas
Melissa A. Thill
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Fenwal Inc
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Fenwal Inc
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    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61M—DEVICES FOR INTRODUCING MEDIA INTO, OR ONTO, THE BODY; DEVICES FOR TRANSDUCING BODY MEDIA OR FOR TAKING MEDIA FROM THE BODY; DEVICES FOR PRODUCING OR ENDING SLEEP OR STUPOR
    • A61M1/00—Suction or pumping devices for medical purposes; Devices for carrying-off, for treatment of, or for carrying-over, body-liquids; Drainage systems
    • A61M1/34—Filtering material out of the blood by passing it through a membrane, i.e. hemofiltration or diafiltration
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61M—DEVICES FOR INTRODUCING MEDIA INTO, OR ONTO, THE BODY; DEVICES FOR TRANSDUCING BODY MEDIA OR FOR TAKING MEDIA FROM THE BODY; DEVICES FOR PRODUCING OR ENDING SLEEP OR STUPOR
    • A61M1/00—Suction or pumping devices for medical purposes; Devices for carrying-off, for treatment of, or for carrying-over, body-liquids; Drainage systems
    • A61M1/14—Dialysis systems; Artificial kidneys; Blood oxygenators ; Reciprocating systems for treatment of body fluids, e.g. single needle systems for hemofiltration or pheresis
    • A61M1/16—Dialysis systems; Artificial kidneys; Blood oxygenators ; Reciprocating systems for treatment of body fluids, e.g. single needle systems for hemofiltration or pheresis with membranes
    • A61M1/1601—Control or regulation
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61M—DEVICES FOR INTRODUCING MEDIA INTO, OR ONTO, THE BODY; DEVICES FOR TRANSDUCING BODY MEDIA OR FOR TAKING MEDIA FROM THE BODY; DEVICES FOR PRODUCING OR ENDING SLEEP OR STUPOR
    • A61M1/00—Suction or pumping devices for medical purposes; Devices for carrying-off, for treatment of, or for carrying-over, body-liquids; Drainage systems
    • A61M1/14—Dialysis systems; Artificial kidneys; Blood oxygenators ; Reciprocating systems for treatment of body fluids, e.g. single needle systems for hemofiltration or pheresis
    • A61M1/16—Dialysis systems; Artificial kidneys; Blood oxygenators ; Reciprocating systems for treatment of body fluids, e.g. single needle systems for hemofiltration or pheresis with membranes
    • A61M1/26—Dialysis systems; Artificial kidneys; Blood oxygenators ; Reciprocating systems for treatment of body fluids, e.g. single needle systems for hemofiltration or pheresis with membranes and internal elements which are moving
    • A61M1/262—Dialysis systems; Artificial kidneys; Blood oxygenators ; Reciprocating systems for treatment of body fluids, e.g. single needle systems for hemofiltration or pheresis with membranes and internal elements which are moving rotating
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61M—DEVICES FOR INTRODUCING MEDIA INTO, OR ONTO, THE BODY; DEVICES FOR TRANSDUCING BODY MEDIA OR FOR TAKING MEDIA FROM THE BODY; DEVICES FOR PRODUCING OR ENDING SLEEP OR STUPOR
    • A61M1/00—Suction or pumping devices for medical purposes; Devices for carrying-off, for treatment of, or for carrying-over, body-liquids; Drainage systems
    • A61M1/14—Dialysis systems; Artificial kidneys; Blood oxygenators ; Reciprocating systems for treatment of body fluids, e.g. single needle systems for hemofiltration or pheresis
    • A61M1/16—Dialysis systems; Artificial kidneys; Blood oxygenators ; Reciprocating systems for treatment of body fluids, e.g. single needle systems for hemofiltration or pheresis with membranes
    • A61M1/26—Dialysis systems; Artificial kidneys; Blood oxygenators ; Reciprocating systems for treatment of body fluids, e.g. single needle systems for hemofiltration or pheresis with membranes and internal elements which are moving
    • A61M1/262—Dialysis systems; Artificial kidneys; Blood oxygenators ; Reciprocating systems for treatment of body fluids, e.g. single needle systems for hemofiltration or pheresis with membranes and internal elements which are moving rotating
    • A61M1/265—Dialysis systems; Artificial kidneys; Blood oxygenators ; Reciprocating systems for treatment of body fluids, e.g. single needle systems for hemofiltration or pheresis with membranes and internal elements which are moving rotating inducing Taylor vortices
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61M—DEVICES FOR INTRODUCING MEDIA INTO, OR ONTO, THE BODY; DEVICES FOR TRANSDUCING BODY MEDIA OR FOR TAKING MEDIA FROM THE BODY; DEVICES FOR PRODUCING OR ENDING SLEEP OR STUPOR
    • A61M1/00—Suction or pumping devices for medical purposes; Devices for carrying-off, for treatment of, or for carrying-over, body-liquids; Drainage systems
    • A61M1/34—Filtering material out of the blood by passing it through a membrane, i.e. hemofiltration or diafiltration
    • A61M1/3403—Regulation parameters
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61M—DEVICES FOR INTRODUCING MEDIA INTO, OR ONTO, THE BODY; DEVICES FOR TRANSDUCING BODY MEDIA OR FOR TAKING MEDIA FROM THE BODY; DEVICES FOR PRODUCING OR ENDING SLEEP OR STUPOR
    • A61M1/00—Suction or pumping devices for medical purposes; Devices for carrying-off, for treatment of, or for carrying-over, body-liquids; Drainage systems
    • A61M1/34—Filtering material out of the blood by passing it through a membrane, i.e. hemofiltration or diafiltration
    • A61M1/3496—Plasmapheresis; Leucopheresis; Lymphopheresis
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61M—DEVICES FOR INTRODUCING MEDIA INTO, OR ONTO, THE BODY; DEVICES FOR TRANSDUCING BODY MEDIA OR FOR TAKING MEDIA FROM THE BODY; DEVICES FOR PRODUCING OR ENDING SLEEP OR STUPOR
    • A61M1/00—Suction or pumping devices for medical purposes; Devices for carrying-off, for treatment of, or for carrying-over, body-liquids; Drainage systems
    • A61M1/36—Other treatment of blood in a by-pass of the natural circulatory system, e.g. temperature adaptation, irradiation ; Extra-corporeal blood circuits
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61M—DEVICES FOR INTRODUCING MEDIA INTO, OR ONTO, THE BODY; DEVICES FOR TRANSDUCING BODY MEDIA OR FOR TAKING MEDIA FROM THE BODY; DEVICES FOR PRODUCING OR ENDING SLEEP OR STUPOR
    • A61M1/00—Suction or pumping devices for medical purposes; Devices for carrying-off, for treatment of, or for carrying-over, body-liquids; Drainage systems
    • A61M1/36—Other treatment of blood in a by-pass of the natural circulatory system, e.g. temperature adaptation, irradiation ; Extra-corporeal blood circuits
    • A61M1/3621—Extra-corporeal blood circuits
    • A61M1/3622—Extra-corporeal blood circuits with a cassette forming partially or totally the blood circuit
    • A61M1/36222—Details related to the interface between cassette and machine
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61M—DEVICES FOR INTRODUCING MEDIA INTO, OR ONTO, THE BODY; DEVICES FOR TRANSDUCING BODY MEDIA OR FOR TAKING MEDIA FROM THE BODY; DEVICES FOR PRODUCING OR ENDING SLEEP OR STUPOR
    • A61M1/00—Suction or pumping devices for medical purposes; Devices for carrying-off, for treatment of, or for carrying-over, body-liquids; Drainage systems
    • A61M1/36—Other treatment of blood in a by-pass of the natural circulatory system, e.g. temperature adaptation, irradiation ; Extra-corporeal blood circuits
    • A61M1/3693—Other treatment of blood in a by-pass of the natural circulatory system, e.g. temperature adaptation, irradiation ; Extra-corporeal blood circuits using separation based on different densities of components, e.g. centrifuging
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61M—DEVICES FOR INTRODUCING MEDIA INTO, OR ONTO, THE BODY; DEVICES FOR TRANSDUCING BODY MEDIA OR FOR TAKING MEDIA FROM THE BODY; DEVICES FOR PRODUCING OR ENDING SLEEP OR STUPOR
    • A61M2205/00—General characteristics of the apparatus
    • A61M2205/18—General characteristics of the apparatus with alarm
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61M—DEVICES FOR INTRODUCING MEDIA INTO, OR ONTO, THE BODY; DEVICES FOR TRANSDUCING BODY MEDIA OR FOR TAKING MEDIA FROM THE BODY; DEVICES FOR PRODUCING OR ENDING SLEEP OR STUPOR
    • A61M2205/00—General characteristics of the apparatus
    • A61M2205/33—Controlling, regulating or measuring
    • A61M2205/3331—Pressure; Flow
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61M—DEVICES FOR INTRODUCING MEDIA INTO, OR ONTO, THE BODY; DEVICES FOR TRANSDUCING BODY MEDIA OR FOR TAKING MEDIA FROM THE BODY; DEVICES FOR PRODUCING OR ENDING SLEEP OR STUPOR
    • A61M2205/00—General characteristics of the apparatus
    • A61M2205/33—Controlling, regulating or measuring
    • A61M2205/3331—Pressure; Flow
    • A61M2205/3334—Measuring or controlling the flow rate
    • C—CHEMISTRY; METALLURGY
    • C12—BIOCHEMISTRY; BEER; SPIRITS; WINE; VINEGAR; MICROBIOLOGY; ENZYMOLOGY; MUTATION OR GENETIC ENGINEERING
    • C12N—MICROORGANISMS OR ENZYMES; COMPOSITIONS THEREOF; PROPAGATING, PRESERVING, OR MAINTAINING MICROORGANISMS; MUTATION OR GENETIC ENGINEERING; CULTURE MEDIA
    • C12N5/00—Undifferentiated human, animal or plant cells, e.g. cell lines; Tissues; Cultivation or maintenance thereof; Culture media therefor
    • C12N5/06—Animal cells or tissues; Human cells or tissues
    • C12N5/0602—Vertebrate cells
    • C12N5/0634—Cells from the blood or the immune system
    • C12N5/0641—Erythrocytes

Definitions

  • the present disclosure is directed to methods and systems for processing biological fluid. More particularly, the present invention is directed to such methods and systems utilizing a reusable hardware component that includes a pre-programmed controller and a disposable fluid processing circuit mountable on the hardware component.
  • the controller is capable of distinguishing between and among hardware errors of varying types and significance and allows for processing of biological fluid to continue in the event of certain non-operator-correctable hardware errors of a non-critical nature.
  • the various blood processing systems now make it possible to collect and/or process particular blood constituents, instead of whole blood, from a blood source such as, but not limited to, a container of previously collected blood or other living or non-living source.
  • a blood source such as, but not limited to, a container of previously collected blood or other living or non-living source.
  • whole blood is drawn from a blood source, a particular blood component or constituent is separated, removed, and collected, and the remaining blood constituents are returned to the blood source.
  • Removing only particular constituents is advantageous when the blood source is a human donor, because potentially less time is needed for the donor's body to return to pre-donation levels, and donations can be made at more frequent intervals than when whole blood is collected. This increases the overall supply of blood constituents, such as plasma and platelets, made available for transfer and/or therapeutic treatment.
  • Whole blood is typically separated into one or more of its constituents (e.g., red cells, platelets, and plasma) by processing through a disposable fluid flow circuit that is associated with a durable, reusable device that controls the processing of fluid through the flow circuit by a variety of pumps, valves, sensors and the like that operate on the fluid flow circuit.
  • Typical separation techniques include centrifugation, such as in the AMICUS ® separator from Fenwal, Inc., of Lake Zurich, Illinois, or other centrifugal separation devices, or membrane separation such as a spinning membrane-type separator, such as the AUTOPHERESIS-C ® and AURORA ® devices from Fenwal, Inc.
  • apheresis systems in particular, the present subject matter, as seen below, is not limited to such whole blood apheresis applications but may include systems for processing blood components or other biological fluid components.
  • blood components that are not collected are typically returned to the source or subject, such as a patient or donor. These may include concentrated red cells, plasma, platelets or some combination of these. Also, it is common to infuse into the donor or patient a replacement fluid, such as saline, to replace the volume of the blood components that have been removed and not returned.
  • a replacement fluid such as saline
  • such systems include a fluid flow path that communicates with the source or subject, such as but not limited to a human donor or patient, for directing or returning blood, blood components or other fluids to the subject.
  • the fluid flow path is usually in the amended page of the description form of flexible plastic flow tubing terminating in a needle or other access device that is inserted into a subject's (human donor's or patient's) vein.
  • Systems of the type described above often include sensors and/or detectors that monitor various aspects of the biological fluid processing procedure as well as system performance and operation.
  • the system may generate an alarm or an alert informing the operator of the specific condition.
  • the fluid pressure is compared to a threshold and if the fluid pressure is below the threshold value the fluid flow is paused for a selected period. During the selected period the fluid pressure may resolve for example by a donor / patient (e.g. fist squeezing) or by the machine (a pump pause or slowing).
  • a full alarm condition may started, the pumps are stopped and the operator is alerted to intervene and check certain elements of the system.
  • Some conditions may require termination of the biological fluid processing procedure. Others may require some form of operator intervention, correction, and/or acknowledgement.
  • an alert or an alarm requiring operator action adds time to the fluid processing procedure. This can be particularly undesirable where one operator is monitoring several procedures being performed on several devices at the same time such as in a blood center or other facility.
  • processing can resume even in view of a certain (low) level or category of hardware error without the need for operator intervention, nor acknowledgment, nor a complete termination of the procedure.
  • the methods and systems of the present disclosure are particularly advantageous where the only operator action is to resume the procedure and monitor for recurrence of the same issue.
  • the system can carry out and complete this action automatically and independently of the operator.
  • the present disclosure is directed to a method for detecting and correcting errors in an automated biological fluid processing device including a hardware unit comprising a controller including pre-programmed instructions and a disposable fluid circuit mounted on the hardware unit.
  • the method includes a) initiating the procedure in the automated biological fluid processing system; b) detecting non-operator correctable hardware errors of a certain type and category in the hardware unit; c) recognizing said hardware error as being of a certain type and category; d) pausing the processing; e) allowing for a period of time for the system to self-recover; and f) resuming the processing without operator intervention.
  • the present disclosure is directed to a system for processing a biological fluid including a reusable hardware unit comprising a controller including pre-programmed instructions to (a) detect non-operator correctable hardware errors in the hardware unit (b) recognize non-operator correctable hardware errors of varying types in the hardware unit, (c) allow a period of time for said system to correct said error; and (d) allow processing of a biological fluid to continue without operator intervention.
  • the system also includes a disposable fluid processing circuit mounted on the hardware unit.
  • the present disclosure is directed to methods and systems for processing a biological fluid such as, but not limited to, blood.
  • a durable or reusable hardware unit in combination with a separate fluid processing circuit (which may be disposable) to separate a plasma-containing fluid into separated plasma and a concentrated fluid.
  • Figs. 1 and 2 illustrate an exemplary fluid separation system 10
  • Fig. 3 illustrates an exemplary fluid flow circuit 12 mounted onto the hardware unit 13, but it should be understood that the illustrated fluid separation system 10 and fluid processing circuit 12 are merely exemplary of such systems and circuits and that differently configured fluid processing systems and fluid flow circuits may be provided without departing from the scope of the present disclosure.
  • the system 10 of Fig. 1 is configured for processing whole blood, but it may be used to process other biological fluids.
  • the fluid may come from any fluid source and be returned to any recipient, which may be the same as or different from the fluid source.
  • the fluid source/recipient is a living donor or patient (e.g., a human blood donor), while in other embodiments the fluid source, subject and/or fluid recipient may be a non-living source/recipient (e.g., a blood bag or other fluid container).
  • the claimed methods are limited to non-living sources of biological fluid and do not encompass a step of returning fluid to a recipient of biological fluid.
  • the illustrated system 10 includes the hardware unit 13 shown as a cabinet or housing 14, with several components positioned outside of the cabinet 14 (e.g., associated with a front wall or surface or panel of the cabinet 14) and additional components (including a central processing unit or controller 16, such as programmable micro-processor based controller) and interconnects positioned inside of the cabinet 14, which may be accessed by opening a rear door 18 of the system 10, as shown in Fig. 2 .
  • Controller is used generally and may include any higher or lower level processors that are part of the overall control or operation of the system or process, whether combined in a single processing unit or separate discrete components or structures.
  • one or more pumps or pump stations 20a-20c may be provided, with the pumps 20a-20c configured to accommodate tubing lines of the fluid flow circuit 12.
  • One of the pumps 20a may be provided as a source/recipient access pump, which may be associated with a source/recipient access or fluid flow path or line 22 of the fluid flow circuit 12 and operates to draw fluid from a fluid source ( Fig. 5 ) and to return fluid to a fluid recipient ( Fig. 6 ).
  • Another one of the pumps 20b may be provided as an anticoagulant pump, which may be associated with an anticoagulant line 24 of the fluid flow circuit 12 and operates to add anticoagulant from an anticoagulant source or container 26 of the fluid flow circuit 12 ( Fig.
  • a third pump 20c may be provided as a return fluid pump, which may be associated with a return fluid outlet line 30 and operates to draw a return fluid (i.e., a fluid constituent to be returned or infused into a fluid recipient) from the fluid separation chamber 28 and direct it into a return fluid reservoir 32 after the fluid has been separated into a return fluid and a collection fluid in the fluid separation chamber 28.
  • the fluid return or infusion pump 20c may also be referred to as a red cell pump in the illustrated embodiment, as red cell concentrate may be a typical fluid returned to a donor in a procedure where the primary collection target is plasma.
  • the pumps 20a-20c are rotary peristaltic pumps, but it is within the scope of the present disclosure for differently configured pumps, such as diaphragm or other pumps, to be provided. Furthermore, additional or alternative pumps may be provided without departing from the scope of the present disclosure.
  • a pump may be associated with a collection fluid outlet line 34 of the fluid flow circuit 12 to draw a collection fluid from the fluid separation chamber 28 after the fluid from the fluid source has been separated into a return fluid and a collection fluid.
  • the illustrated embodiment employs a single fluid flow tubing or flow path for both drawing fluid from a source and flowing or returning it to a recipient, which are carried out intermittently.
  • the system 10 could employ separate draw and return flow paths or tubes without departing from the scope of the present disclosure.
  • the external components of the system 10 may include one or more clamps or valves 36a-36d associated with the tubing lines of the fluid flow circuit 12.
  • the clamps or valves 36a-36d may be variously configured and operate to selectively allow and prevent fluid flow through the associated tubing line.
  • one clamp or valve 36a may be provided as a fluid source/recipient clamp, which may be associated with a draw branch 22a of the source/recipient access line 22 of the fluid flow circuit 12 to allow ( Fig. 5 ) or prevent ( Fig. 6 ) the flow of fluid through the draw branch 22a of the source/recipient access line 22.
  • clamps or valves 36b may be provided as a reinfusion clamp or valve, which may be associated with a reinfusion branch 22b of the source/recipient access line 22 downstream of a return fluid reservoir 32 of the fluid flow circuit 12 to allow ( Fig. 6 ) or prevent ( Fig. 5 ) the flow of return or replacement fluid through the infusion branch 22b.
  • a third clamp or valve 36c may be provided as a collection fluid clamp or valve, which may be associated with the collection fluid outlet line 34 to allow ( Fig. 5 ) or prevent ( Fig. 6 ) the flow of collection fluid through the collection fluid outlet line 34 and into a collection fluid container 38.
  • a fourth clamp or valve 36d may be provided as a replacement fluid clamp or valve, which may be associated with a replacement fluid line 40 of the fluid flow circuit 12 to allow or prevent the flow of a replacement fluid out of a replacement fluid source 42 (e.g., a bag or container at least partially filled with saline). Additional or alternative clamps or valves may also be provided without departing from the scope of the present disclosure.
  • a replacement fluid source 42 e.g., a bag or container at least partially filled with saline. Additional or alternative clamps or valves may also be provided without departing from the scope of the present disclosure.
  • the illustrated system 10 further includes one or more pressure sensors 43a and 43b of conventional design that may be associated with the fluid flow circuit 12 to monitor the pressure within one or more of the tubing lines of the fluid flow circuit 12 during operation of the pumps 20a-20c and clamps or valves 36a-36d.
  • one pressure sensor 43a may be associated with a tubing line that draws fluid (for example whole blood) from a fluid source and/or directs processed or replacement fluid (for example blood components, such as red cell concentrate, and/or saline) to a fluid recipient or subject
  • the other pressure sensor 43b may be associated with a tubing line that directs fluid into or out of the fluid separation chamber 28 to assess the pressure within the fluid separation chamber 28, but the pressure sensors 43a and 43b may also be associated with other tubing lines without departing from the scope of the present disclosure.
  • the pressure sensors 43a and 43b may send signals to the system controller 16 that are indicative of the pressure within the tubing line or lines being monitored by the pressure sensor 43a, 43b.
  • the controller 16 may generate an alarm and/or instruct one or more of the pumps 20a-20c and/or one or more of the clamps or valves 36a-36d to act so as to alleviate the improper pressure condition (e.g., by changing the fluid flow rate, reversing the direction of operation of one of the pumps 20a-20c and/or opening or closing one of the clamps or valves 36a-36d). Additional or alternative pressure sensors may also be provided without departing from the scope of the present disclosure.
  • the system 10, and more specifically, hardware unit 13 may also include a separation actuator 44 that interacts with a portion of the fluid separation chamber 28 to operate the fluid separation chamber or separator 28.
  • a chamber lock 46 may also be provided to hold the fluid separation chamber or separator 28 in place with respect to the system cabinet 14 and in engagement with the separation actuator 44.
  • the configuration and operation of the separation actuator 44 depends upon the configuration of the fluid separator 28.
  • the fluid separator 28 is provided as a spinning membrane-type separator, such as a separator of the type described in greater detail in U.S. Patents Nos. 5,194,145 and 5,234,608 or in PCT Patent Application Publication No. WO 2012/125457 A1 .
  • the fluid separation chamber 28 may include a tubular housing 48 ( Fig. 4 ), with a microporous membrane 50 positioned therein.
  • An inlet 52 allows a fluid from a fluid source to enter into the housing 48 (via the draw branch 22a of the source/recipient access line 22), while a side outlet 54 allows return fluid to exit the housing 48 (via the return fluid outlet line 30) and a bottom outlet 56 allows collection fluid to exit the housing 48 (via the collection fluid outlet line 34) after the fluid from the fluid source has been separated into return fluid and collection fluid.
  • the separation actuator 44 is provided as a driver that is magnetically coupled to a rotor 58 on which the membrane 50 is mounted, with the separation actuator 44 causing the rotor 58 and membrane 50 to rotate about the central axis of the housing 48.
  • the rotating rotor 58 and membrane 50 create Taylor vortices within a gap 60 between the housing 48 and the membrane 50, which tend to transport the return fluid away from the membrane 50 to exit the fluid separation chamber 28 via the side outlet 54, while the collection fluid passes through the membrane 50 toward the central axis of the housing 48 to exit the fluid separation chamber 28 via the bottom outlet 56.
  • whole blood from a blood source is separated into cellular blood components (return fluid) and substantially cell-free plasma (collection fluid).
  • the present disclosure is not limited to a particular fluid separation chamber and that the illustrated and described fluid separation chamber 28 is merely exemplary.
  • a differently configured spinning membrane-type fluid separation chamber may be employed (e.g., one in which the membrane 50 is mounted on an inside surface of the housing 48 or on both the rotor 58 and an inside surface of the housing 48 and facing the gap 60), or a centrifugal separation chamber or other design without departing from the scope of the present disclosure.
  • the illustrated membrane material may be formed into a sheet or film using any suitable techniques to define the membrane 50 that is to be mounted onto the rotor 58 of the fluid separation chamber 28.
  • the dimensions and configuration of the membrane 50 may vary without departing from the scope of the present disclosure, but in one embodiment a membrane 50 such as described above, and used for separation of whole blood into plasma and cellular components may have a thickness in the range of approximately 5 ⁇ m to approximately 1000 ⁇ m (preferably in the range of approximately 25 ⁇ m to approximately 200 ⁇ m), with a mean pore size in the range of approximately 0.2 ⁇ m to approximately 200 (preferably in the range of approximately 0.5 ⁇ m to approximately 10 ⁇ m and more preferably in the range of approximately 0.6 ⁇ m to approximately 5 ⁇ m).
  • the porosity of the membrane 50 may also vary, such as from approximately 1 % to approximately 90%, but preferably in the range of approximately 50% to approximately 80% to produce a membrane 50 that passes fluid therethrough at a relatively high rate while being sufficiently strong to withstand the forces applied to it by the spinning rotor 58 and fluid contact during a separation procedure.
  • a fluid is drawn from a fluid source into the fluid separation chamber 28, or a temporary holding chamber, during a draw phase or mode ( Fig. 5 ), where it is separated into return fluid (e.g., cellular blood components) and collection fluid (e.g., substantially cell-free plasma).
  • return fluid e.g., cellular blood components
  • collection fluid e.g., substantially cell-free plasma
  • the collection fluid is retained by the system 10, while the return fluid is temporarily retained and returned to the fluid source during a return or infusion phase or mode ( Fig. 6 ).
  • Fig. 7 shows an exemplary phase or mode in which replacement fluid (e.g., saline) is directed to the fluid recipient, either alone or with an amount of return/processed fluid.
  • replacement fluid e.g., saline
  • the clamp or valve 36d associated with the replacement fluid line 40 is opened to allow replacement fluid to flow out of the replacement fluid source 42.
  • the clamp or valve 36a associated with the draw branch 22a of the source/recipient access line 22 may be in a closed condition to prevent fluid flow therethrough, such that the replacement fluid is directed into the fluid separation chamber 28.
  • the replacement fluid is pulled out of the fluid separation chamber 28 and into the return fluid reservoir 32 by operation of the pump 20c associated with the return fluid outlet line 30. If there is any return fluid in the return fluid reservoir 32, then the replacement fluid mixes with the return fluid prior to being pumped to the fluid recipient by the pump 20a associated with the fluid recipient line 22, otherwise the replacement fluid alone may be pumped to the fluid recipient.
  • the replacement fluid return mode of Fig. 7 may be carried out at other times, such as earlier in the procedure, at multiple scheduled times during a procedure, and/or at any time upon a request from the operator and/or using a different path between the replacement fluid source 42 and the fluid recipient.
  • the replacement fluid may bypass the fluid separation chamber and the return fluid reservoir 32 if the replacement fluid is being pumped to a fluid recipient earlier in the procedure.
  • the clamp or valve 36d associated with the replacement fluid line 40 and the clamp or valve 36a associated with the draw branch 22a of the source/recipient access line 22 may be opened to allow fluid flow therethrough, with the clamp or valve 36b associated with the reinfusion branch 22b in a closed condition to prevent fluid flow therethrough.
  • the pump 20a associated with the fluid recipient line 22 may be activated (with the other two pumps 20b and 20c inactive) to draw replacement fluid out of the replacement fluid source 42 and through the replacement fluid line 40, the draw branch 22a, and finally the source/recipient access line 22 to the fluid recipient.
  • the draw and return phases are repeatedly alternated (drawing from the fluid source, separating the fluid from the fluid source into return fluid and collection fluid, and then pumping the return fluid and/or a replacement fluid to the fluid source or a different recipient) until a target (e.g., a particular amount of collection fluid) is achieved.
  • All of the draw phases and all of the return phases may be identical or may differ from each other. For example, a final draw phase may draw less fluid from the fluid source than the previous draw phases and a final return phase may infuse a combination of return fluid and replacement fluid to the fluid recipient, whereas the previous return phases pump might only return fluid to the fluid recipient.
  • Systems of the type described above include several sensors/detectors that are built into hardware component 13 and communicate with the controller. Such sensors/detectors may detect the status of the procedure, conditions of the donor/patient, conditions within the fluid processing circuit 12 (e.g., pressure, flow rate), and errors in the hardware. As shown in Fig. 8 , with regard to such hardware errors 70, they can range in severity and importance from those requiring termination of the procedure to those requiring intervention or acknowledgement by the operator to those that cannot be corrected but pose no harm to the safety of the patient. In accordance with the present disclosure, the controller is pre-programmed to recognize the category of the hardware error (step 72).
  • the controller may automatically generate an alarm (step 74) requiring termination of the procedure (step 75.)
  • the controller may generate an alert (step 76) that may require intervention and/or acknowledgement (step 78) by the operator. Alerts and/or alarms may be graphical, textual, and/or audible.
  • the controller may also optionally generate a (graphical and/or textual) message shown in step 80 to the operator that an error that cannot be corrected but is otherwise of a category that poses no danger to the safety of the patient has occurred.
  • hardware errors include and may include, without limitation pump and spinner rate errors (e.g., if the spinner is spinning too fast, too slow, is stalled, is not changing rates, is not stopping fast enough, or the direction of spin is reversed); clamps that do not open/close when intended; disturbances on the weight scales that increase signal variation /noise, but do not affect the average reading; inflation of the pressure cuff for a long period of time; readings of the pressure sensors that are outside of the normal range, but not hazardous; analog-to-digital conversions that did not complete as expected.
  • pump and spinner rate errors e.g., if the spinner is spinning too fast, too slow, is stalled, is not changing rates, is not stopping fast enough, or the direction of spin is reversed
  • clamps that do
  • the system and the processing of the biological fluid may be paused temporarily for a selected period of time, as shown in step 82.
  • the length of the pause may range anywhere between 0 seconds and 60 seconds. In a more particular embodiment, the length of the pause may be approximately 10 or fewer seconds. In any event, the pause should not be so long so as to add significant time to the processing procedure. The pause is not considered to be a termination of the procedure. As shown in Fig. 8 , the pause at step 82 allows a period of time for the device to correct the error or otherwise self-recover.
  • self-recovery may include one or more of the following steps: pulling power from the pumps, allowing the pumps to stop, restoring power to the pumps, and resuming the procedure/re-trying the previous procedure state.
  • self-recovery includes deflation of the cuff, pausing of the procedure, and re-inflation the cuff.
  • self-recovery includes stoppage of fluid flow into/out of the container on the scale and ensuring that no continued disturbance/noise or a change in the average reading is present.
  • analog-to-digital conversion errors the system pauses all hardware activities, re-establishes analog-to-digital conversion, and then resumes. In any event, processing of the biological fluid will resume, as shown in step 84.
  • system 10 may keep track of such non-operator-correctable hardware errors of the type described above, as indicated in step 81.
  • the controller may be pre-programmed such that if the number of non-operator-correctable hardware errors, either within a certain category of a non-operator-correctable error or all non-operator-correctable errors as whole reaches or exceeds a pre-selected value, the system may generate an alarm or alert in accordance with the protocol that requires termination of the procedure or operator intervention in response to more serious hardware errors, as described above and shown in steps 74 and 76, respectively.
  • the system may continue through the pause and self-recovery steps (82) and "resume processing" step (84), as described above relative to such errors.

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Claims (14)

  1. Verfahren zur Verarbeitung einer biologischen Flüssigkeit in einem automatisierten Verarbeitungssystem (10) für eine biologische Flüssigkeit, wobei die biologische Flüssigkeit von einer nichtlebenden Quelle ist, das System (10) eine Hardware-Einheit (13) aufweisend eine Steuerung (16), die vorprogrammierte Anweisungen umfasst, und einen Einwegflüssigkeitskreislauf (12) umfasst, der auf der Hardware-Einheit (13) montiert ist, wobei das Verfahren umfasst:
    a) Initiieren der Verarbeitung in dem automatisierten Verarbeitungssystem für eine biologische Flüssigkeit;
    b) Detektieren von nicht vom Bediener korrigierbaren Hardware-Fehlern eines bestimmten Typs und einer bestimmten Kategorie in der Hardware-Einheit (13);
    c) Erkennen des Hardware-Fehlers als von einem bestimmten Typ und einer bestimmten Kategorie;
    d) Pausieren der Verarbeitung;
    e) Zulassen eines Zeitraums, in dem das System sich selbst wieder herstellen kann; und
    f) Wiederaufnehmen der Verarbeitung ohne Intervention des Bedieners.
  2. Verfahren nach Anspruch 1, umfassend ein Pausieren der Verarbeitung ohne ein Abbrechen der Verarbeitung.
  3. Verfahren nach Anspruch 2, umfassend ein Pausieren der Verarbeitung für weniger als 60 Sekunden.
  4. Verfahren nach einem der Ansprüche 1 und 2, umfassend ein Verarbeiten von Blut, um das Blut in zwei oder mehr Komponenten zu trennen.
  5. Verfahren nach einem der Ansprüche 1 bis 3, des Weiteren umfassend ein Erkennen von unterschiedlichen Typen und Kategorien von Fehlern in der Hardware-Einheit (13) .
  6. Verfahren nach einem der vorhergehenden Ansprüche 1 bis 5, des Weiteren umfassend ein Korrigieren des Fehlers ohne Intervention des Bedieners.
  7. Verfahren nach einem der vorhergehenden Ansprüche 1 bis 5, des Weiteren umfassend ein Generieren eines Alarms oder einer Warnung, wenn ein oder mehrere Fehler in der Hardware-Einheit (13) detektiert werden und ein oder mehrere der Fehler nicht korrigiert werden.
  8. Verfahren nach Anspruch 7, wobei der Alarm oder die Warnung ein akustisches Signal und/oder eine grafische/Textmeldung umfasst.
  9. Verfahren nach einem der vorhergehenden Ansprüche 1 bis 8, wobei ein nicht vom Bediener korrigierbarer Hardware-Fehler in der Hardware-Einheit (13) ein Fehler ausgewählt aus der Gruppe bestehend aus: Pumpen- und Propellerratenfehler; sich nicht wie vorgesehen öffnende/schließende Klemmen (36a-36d); Störungen auf den Gewichtswaagen, die Signalschwankungen/-rauschen verstärken; Befüllung der Druckmanschette für einen langen Zeitraum; Auslesungen der Drucksensoren (43a, 43b), die außerhalb des normalen Bereichs liegen, jedoch nicht gefährlich sind; Analog/Digital-Konvertierungen, die nicht wie erwartet abgeschlossen wurden, ist.
  10. System (10) zum Verarbeiten einer biologischen Flüssigkeit, umfassend:
    a) eine wiederverwendbare Hardware-Einheit (13), umfassend eine Steuerung (16), die vorprogrammierte Anweisungen einschließt zum:
    i) Detektieren von nicht vom Bediener korrigierbaren Hardware-Fehlern in der Hardware-Einheit (13);
    ii) Erkennen von nicht vom Bediener korrigierbaren Hardware-Fehlern verschiedener Typen in der Hardware-Einheit (13);
    iii) Pausieren des Systems und der Verarbeitung der biologischen Flüssigkeit zeitweilig für einen ausgewählten Zeitraum, um zuzulassen, dass das System den Fehler korrigiert; und
    iv) Zulassen des Fortfahrens der Verarbeitung einer biologischen Flüssigkeit ohne Intervention des Bedieners;
    b) einen Einweg-Fluidverarbeitungskreislauf (12), der auf der Hardwareeinheit (13) montiert ist.
  11. System (10) nach Anspruch 10, wobei die Steuerung (16) Anweisungen zum Generieren eines Alarms oder einer Warnung in Reaktion auf einen detektierten Fehler eines bestimmten Typs in der Hardware-Einheit (13) einschließt.
  12. System (10) nach einem der vorhergehenden Ansprüche 10 und 11, wobei die Steuerung (16) vorprogrammiert ist, um einen Verarbeitungsvorgang für eine biologische Flüssigkeit bei Erkennung eines bestimmten Typs des Fehlers in der Hardware-Einheit (13) zu pausieren.
  13. System (10) nach einem der vorhergehenden Anspruch 10 bis 12, wobei die Steuerung (16) vorprogrammiert ist, um das Vorkommen der Hardware-Fehler aufzuzeichnen.
  14. System (10) nach Anspruch 13, wobei die Steuerung (16) eine Nachricht oder einen Alarm oder eine Warnung generiert, wenn die Steuerung eine vorbestimmte Anzahl der Hardware-Fehler aufzeichnet.
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